Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07393594
Eligibility Criteria:
Inclusion Criteria:
* Participants must meet all the following criteria:
* Written informed consent and HIPAA authorization obtained prior to any study-related data collection.
* Age ≥18 years at the time of enrollment.
* Recipient of a kidney transplant, including:
* Primary or repeat kidney transplantation
* Living-donor or deceased-donor transplantation
* At 1 month post-kidney transplant at the time of enrollment.
* Receiving maintenance immunosuppressive therapy per institutional standard of care.
* Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.
Exclusion Criteria:
* Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation.
* History of prior non-renal solid organ transplantation or islet cell transplantation.
* Known pregnancy at the time of enrollment.
* Known active viral infection at enrollment with any of the following:
* Hepatitis B surface antigen (HBsAg)-positive
* Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive
* Human immunodeficiency virus (HIV) infection or HIV NAT-positive
* \*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.
* Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures.
* Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.
* Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07393594
Study Brief:
Protocol Section:
NCT07393594